Medtronic plc (MDT) Q1 2013 Earnings Report, Transcript and Summary

Good morning. My name is Christie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Medtronic's First Quarter Earnings Release Conference Call. [Operator Instructions] Thank you. It is now my pleasure to hand the program over to Mr. Jeff Warren. Please go ahead.

Thank you, Christie. Good morning, and welcome to Medtronic's First Quarter Conference Call and Webcast. During the next hour, Omar Ishrak, Medtronic Chairman and Chief Executive Officer; and Gary Ellis, Medtronic Chief Financial Officer, will provide comments on the results of our fiscal year 2013 first quarter, which ended July 27, 2012. After our prepared remarks, we will be happy to take your questions. First, a few logistical comments. Earlier this morning, we issued a press release containing our financial statements and a revenue-by-business summary. Should also note that some of the statements made during this call may be considered forward-looking statements and that actual results might differ materially from those projected in any forward-looking statement. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. Therefore, we do not undertake to update any forward-looking statement. In addition, the reconciliations of any non-GAAP financial measures are available on the Investors' portion of our website at medtronic.com. Finally, unless we say otherwise, references to quarterly results, increasing or decreasing, are in comparison to the first quarter of fiscal year 2012, and all year-over-year revenue growth rates are given on a constant currency basis. With that, I'm now pleased to turn the call over to Medtronic Chairman and Chief Executive Officer, Omar Ishrak.

Good morning, and thank you, Jeff, and thank you to everyone for joining us today. This morning, we reported first quarter revenue of $4 billion, which represents growth of 5%. Q1 non-GAAP earnings of $883 million and diluted earnings per share of $0.85 increased 4% and 8%, respectively. It is worth pointing out that we delivered these results while covering $0.01 or $0.02 of negative EPS impact from bad debt of a Greek distributor and higher-than-expected tax expense. Gary will discuss these items later. Our Q1 results represent another positive step toward our goal of delivering consistent and dependable growth. Two of our larger end markets, U.S. ICD and U.S. Spine, which have been under pressure, continue to show signs of stabilization. At the same time, our results reflect the positive operational impact of our strategies and market-leading technologies, both in developed and emerging markets. There is still a lot of work to be done, and we're just at the beginning of our efforts. But we're encouraged that our actions and improving execution are beginning to yield some results. Let me start with the U.S. ICDs. We estimate the market declined approximately 4%, the best it has been in 6 quarters. While the market did see the normal impact of our Q4 to Q1 seasonality, we were pleased to see relative sequential stability. Our U.S. ICD business was down 3% in Q1, slightly better than the market. Pricing was down around 4%, which was consistent with the previous quarter. Our implant volumes were up 4%, but this growth was offset by hospitals reducing their level of bulk purchases, which are now at the lowest level in nearly 5 years. This reduction in bulk purchases is a trend we have seen over the last 4 quarters. And looking ahead, we would expect the stabilization in the U.S. market to continue. Turning to U.S. Spine. We estimate that U.S. Core Spine market was flat and has now modestly improved over the past 3 quarters. Stabilization was also evident in our own results as our U.S. Core Spine business was flat this quarter. Our business seems to be turning the corner as our new products and procedures gain critical mass. Our continued focus on navigated spinal procedures and enabling technologies, such as POWEREASE, is attracting more surgeon interest and improving our Spine financial results. Strong capital equipment sales in our Surgical Technologies business further demonstrate the importance of these technologies. And as a result, our U.S. Core Spine share is stable year-over-year, and we estimate we gained modest share sequentially in Q1. Although we are pleased with the progress we are making, it is still very early, and we have to build on this momentum and deliver consistent results over time. The other part of our U.S. Spine business, BMP, declined 20% in Q1. As you know, questions were raised at -- last year about INFUSE, and to better understand the facts, we requested Yale University to perform an unprecedented systematic analysis of all the available data. While the timing is controlled by Yale, we are expecting the result to be published in the coming months. The remainder of our business also performed well with some standout performances in areas where new products are making a difference. In Coronary, our Resolute Integrity drug-eluting stent picked up an additional 7 points of share in the U.S. this quarter, nearly tripling our share over the past 2 quarters. In Endovascular, the launch of our Endurant abdominal aortic stent graft in Japan and the release of Endurant II in the U.S. and in Europe are driving strong growth in our aortic business. Across the balance of our CVG portfolio, we continue to see double-digit growth in transcatheter valves, in AF ablation and our peripheral interventional product lines. In RTG, our recently launched RestoreSensor is gaining solid market acceptance and resulting in improved growth in Pain Stim. Additionally, we continue to see double-digit growth across the RTG portfolio, in DBS, Gastro, Uro, CGM, navigation and ENT. While our teams are executing well on recent product launches, we are also making progress on advancing our industry-leading product pipeline. In transcatheter valves, we expect to complete enrollment in our CoreValve U.S. high-risk arm in the coming weeks. In renal denervation, we're continuing enrollment in our SYMPLICITY HTN-3 U.S. pivotal trial and remain on track to complete enrollment during the first calendar quarter of next year. We also continue to advance our drug-eluting balloon program as we enroll patients in our IN.PACT SFA II U.S. pivotal study. While these are all longer-term programs, we also have important programs that we expect to launch in the next 12 months. In CRDM, we have received CE Mark approval for the Viva and Brava families of next-generation, high-power CRT-D products. In Spine, we anticipate U.S. approval later this fiscal year for our BRYAN ACD Cervical Disc, which we believe will take share in the growing cervical arthroplasty market. We also expect to launch new interbody implants from our AMT acquisition in the NASS conference in October. And finally, in Diabetes, we're targeting U.S. approval of our MiniMed 530G pump, as well as our Enlite Sensor late this fiscal year. Our international revenue grew 6% in Q1, including 4% growth in Western Europe, which has remained relatively stable over the past several quarters. Our European growth varied by country with stronger growth in the north, including double-digit growth in France, the U.K. and Ireland, but partially offset by softness in Southern Europe. However, we are seeing signs that Southern Europe -- that the Southern European governments are focusing on ways to better support their healthcare systems. For example, in Spain and Italy, they both recently made some significant payments on the outstanding payables to us. While we're encouraged by these positive signs, we're obviously continuing to watch Europe very closely. Overall, our developed markets, including the U.S., showed improved growth this quarter, and our emerging markets grew 14%. Although this performance in emerging markets is respectable, I was disappointed in that it was below the 20% level that we've been targeting and expect to deliver consistently over the longer term. As I mentioned in our investor meeting in June, we feel that emerging market growth, combined with market stabilization, as well as our strong portfolio and pipeline, provides the foundation to deliver consistent top and bottom line growth over the midterm. But over the longer term, we must position ourselves to succeed in the rapidly changing global healthcare market. To do this, we're building upon our strength and remain focused in 2 main long-term strategies, creating economic value and accelerating globalization. As I continue to reach out to our customers around the world, I'm further convinced that these are the right strategies. These customer interactions also provide further clarity of the new kinds of partnerships needed to win in the changing healthcare environment. The ability to deliver economic value is increasingly important, especially in the U.S. and Europe, as the market clearly shifts from paper procedure to paper value. Likewise, with globalization, there's an increasing need to address inequity in access to healthcare for people around the world, particularly for our therapies. In order to fully capitalize on these strategies, we are improving the operating rigor across the company. We remain focused on reducing product cost by $1.2 billion over the next 5 years. This is important not only to maintain our gross margins, but it also fuels innovation in tiered products, which are essential to our strategies for us succeeding in the emerging value segment. We are also focusing improving working capital, and I've set a goal for the company to meaningfully improve our inventory turns. In that regard, we recently adjusted our incentive programs to drive better inventory management. Improvements like this will strengthen our already robust levels of free cash flow generation. And this leads me to my final point, our commitment to return 50% of our free cash flow to shareholders. As an S&P Dividend Aristocrat, Medtronic has a long history of consistently increasing our dividend. And in June, our Board of Directors once again increased our dividend to a payout ratio of 30%. In fact, over the past 5 years, our dividend has more than doubled. We further supplement our shareholder return through share repurchases and have bought back 13% of our shares over the past 5 years. We feel the commitment to return 50% of our free cash flow to shareholders is appropriate at this point, given our current mix of U.S./o U.S. free cash flow, and we believe that the remaining 50% of our free cash flow provides us with ample flexibility to make investments for sustainable growth. With respect to M&A opportunities, I want to emphasize that we will be very disciplined. We do not intend to pass along EPS dilution to our shareholders, and all transactions will be scrutinized for their ability to meet our high financial hurdles with a particular focus on returns. This commitment is tied directly to the change we made this year in our long-term incentive plan, where return on invested capital now has much greater weight. We believe the combination of our strong capital allocation policies, together with executing on our near and midterm growth drivers and long-term strategies will enable us to create value for our shareholders. Let me now ask Gary to take you through a more detailed look at our results before we take your questions. So, Gary?

Thanks, Omar. First quarter revenue of $4,008,000,000 increased 2% as reported and 5% on a constant currency basis after adjusting for a $119 million unfavorable impact of foreign currency. Q1 revenue results by region were as follows. Growth in Central and Eastern Europe is 21%. Greater China grew 15%. Growth in Middle East and Africa was 14%. South Asia grew 12%. Growth in Latin America was 11%. Western Europe and Canada grew 4%. And growth in U.S. was also 4%, while Asia Pacific grew 2%, including 1% growth in Japan. Emerging markets grew a combined 14% in Q1 and represented 11% of our total sales mix. Q1 GAAP earnings and diluted earnings per share were $864,000,000 and $0.83, an increase of 5% and 8%, respectively. After adjusting for acquisition-related items and the noncash charge for convertible debt interest expense, first quarter earnings and diluted earnings per share on a non-GAAP basis were 888 -- $883 million and $0.85, an increase of 4% and 8% respectively. In our Cardiac and Vascular Group, revenue of $2,115,000,000 grew 4%. Results were driven by solid growth in Coronary, Endovascular, AF Solutions and Structural Heart, partially offset by declines in Pacing. CRDM revenue of $1,193,000,000 declined 2%. Worldwide ICD revenue of $675 million was flat, and we estimate that the worldwide ICD market declined in the low-single digits as we continue to see the U.S. ICD market stabilize. Our Protecta ICD, with its shock reduction and Lead Integrity Alert technologies, combined with the proven long-term performance of our Sprint Quattro leads, continues to receive strong market acceptance. In the U.S., our lead-to-port ratio has returned to the highest level since 2007, and we saw a marked improvement in ICD replacement market share. In Western Europe, our high-power share reached its highest levels in 3 years. Pacing revenue of $463 million declined 6% in line with the market. Our U.S. Pacing revenues declined 10%, also in line with the market. These declines were driven primarily by pricing, which was down in the mid-single digits as we have now anniversaried the market release of the Revo MRI pacemaker family and, to a lesser extent, fewer procedures and reduced hospital bulk purchases. Our AF Solutions business grew nearly 20% globally with growth in excess of 30% in the U.S., driven by the strong performance of our Arctic Front cryoballoon as we continue to gain share in this important growth market. In Q2, we plan to launch our Arctic Front Advance, with its EvenCool technology, in centers in U.S. and Europe. Coronary revenue of $433 million grew 16% on the global strength of Resolute Integrity. Worldwide DES revenue in the quarter was $253 million, including $102 million in the U.S. Resolute Integrity's deliverability, unique diabetes indication [ph] and long-term clinical performance is receiving a strong customer acceptance globally. The rapid capture of DES market share in the U.S. clearly demonstrates the benefits of our broader CVG sales and customer support strategy. It also reinforces our expanding leadership position within the interventional cardiology community, which will continue to expand as we bring forward fundamental new technologies -- new therapies, excuse me, such as transcatheter valves and renal denervation. Next month, we expect to launch Resolute Integrity into the $500 million Japanese DES market. As with the U.S. market, we intend, at a minimum, to double our share. In renal denervation, we continue to lay the groundwork for this important opportunity. Commercially, we are still on the pre-reimbursement phase in many countries, and SYMPLICITY is fighting for discretionary spending in European hospitals that are faced with tightening budgets. Achieving broader reimbursement is going to require more robust clinical data, which we are actively pursuing with both our HTN-3 U.S. pivotal study and our global SYMPLICITY registry. Turning to Structural Heart. Revenue of $280 million increased 7%, driven by strong growth in TAVI. We continue to innovate in this space, leading in the introduction of new sizes and in indications. We launched our CoreValve Evolut 23-millimeter valve in Europe late in Q1. With Evolut, we are now able to serve the broadest range of TAVI patients upon a common 18 French delivery system. On the clinical front, we have a full portfolio of clinical trials designed to drive regulatory approval and therapy expansion. We have begun enrollment of our global CoreValve SURTAVI trial, focused on expanding the market to moderate-risk patients. In our CoreValve U.S. pivotal trial, we completed enrollment in our extreme-risk arm back in January and are in the continued access phase. On the high-risk arm, we expect to be fully enrolled in the coming weeks. Turning to Endovascular. Revenue of $209 million grew 17% with strong balanced growth across our aortic and peripheral businesses. In aortic, growth was driven by the adoption of our next-generation Endurant II abdominal stent graft. In peripheral, we are opening new accounts with our Complete SE stent. Growth is also being driven by the continued adoption of our Assurant Cobalt iliac stent. Our impact drug-eluting balloons delivered strong double-digit growth in international markets, and we are making progress with our IN.PACT global registry and U.S. pivotal study. Now turning to our Restorative Therapies Group. Revenue of $1,893,000,000 grew 5%. Results were driven by growth in Surgical Technologies, Neuromodulation, Diabetes and Core Spine, partially offset by declines in BMP. Spine revenue of $786 million declined 3% globally and 5% in the U.S., mainly driven by declines in BMP. Global Core Spine results of $645 million grew 1% with flat growth in the U.S. These results were in line with the growth of the core spine market, which was roughly flat both globally and in the U.S. It is worth noting that excluding Kyphon, which was slightly down in the U.S. and down low-double digits internationally, our Core Spine business grew 1% in the U.S. and 2% globally. We are seeing improvement in our business as new products and procedures gain scale through increased product family capabilities, number of tests in the field and surgeon training events. In thoracolumbar, we began our full market release of Solera 5.5 and 6.0 in Q1 and nearly doubled our number of Solera Sextant minimally invasive sets in the field. Solera, with its attractive combination of navigation and powered instruments, is generating strong surgeon interest. In cervical, we increased the number of ATLANTIS VISION ELITE cervical plate sets by 20%, which is helping to improve growth. In interbody, although the Q1 revenue from our AMT acquisition was modest due to the limited release, surgeon interest exceeded our expectations. We intend to launch our AMT implants at NASS in October and believe that in addition to improving our interbody growth, these innovative implants will generate pull-through revenue for the rest of our thoracolumbar portfolio. Our Other Biologics portfolio had strong double-digit growth with continued adoption of our Grafton and MagniFuse DBMs. In BMP, revenue of $140 million declined 19%, including a 20% decline in the U.S., although the results were stable sequentially. It is important to note that BMP is one of our lower-margin products, muting its impact to the -- our bottom line. As Omar mentioned, we expect the results of the Yale study on INFUSE to be published in the coming months. Surgical Technologies revenue of $324 million grew 24%, which included $34 million of revenue from Advanced Energy. Organic revenue growth was 11%, driven by strong U.S. sales of capital equipment, including our StealthStation S7, O-Arm and Fusion IGS systems. This strong performance also reflects increased surgeon demand for our navigated spine procedural solutions. In addition to capital sales, Surgical Technologies continues to benefit from balanced growth of disposables and service revenue across our power, monitoring, advanced energy, imaging and navigation platforms. Turning to Neuromodulation. Revenue of $419 million increased 8%. Our Pain Stim business had double-digit growth, driven by sales of our RestoreSensor spinal cord stimulator with AdaptiveStim technology. Our DBS business continued to show strong results, led by solid new implant growth in the U.S. Our Uro/Gastro business delivered another quarter of double-digit growth, driven by adoption of our InterStim Therapy. We also want to let you know that we recently received a warning letter in our Neuromodulation business. We are working with the FDA to resolve the issues, which primarily relate to our complaint handling and catheter [ph] processes. We do not expect it to have a material impact on our financial results. Diabetes revenue of $364 million grew 6%, driven by double-digit growth in CGM. International sales of insulin pumps were also up double digits as Veo, with its low-glucose suspend feature, continues to lead the market. In U.S., we are anticipating FDA approval of the MiniMed 530G insulin pump and Enlite Sensor to occur in late FY '13, which we expect to reaccelerate growth in the U.S. Turning to the rest of the income statement. The Q1 gross margin was 75.7%. Excluding the impact of foreign currency, our gross margin was 75.9%. We continue to offset pricing pressure through our 5-year $1.2 billion cost of goods sales reduction program. For FY '13, we expect gross margins to remain in the range of 75.5% to 76% on an operational basis. First quarter R&D spending of $385 million was 9.6% of revenue. Excluding the impact of foreign currency, the R&D spend was 9.4% of revenue, which was driven by higher clinical trial spending in transcatheter valves and renal denervation. We remain committed to investing in new technologies and evidence creation to drive future growth. And for FY '13, we continue to expect R&D spending to be approximately 9% on an operational basis. First quarter SG&A expenditures of $1,405,000,000 represented 35.1% of sales. In Q1, we recognized $8 million of bad debt due to a single distributor in Greece. Excluding this and the impact of foreign currency, SG&A would have been 34.8% of sales. We continue to focus on several initiatives to leverage our expenses, while at the same time, investing in new product launches and adding to our sales force in faster growing businesses and geographies. In FY '13, we expect to drive 30 to 50 basis points of improvement. Net other expense for the quarter was $39 million. Net gains from our hedging programs were $20 million during the quarter. As you know, we hedge much of our operating results to reduce the volatility in our earnings from foreign exchange. Based on the current exchange rates, we expect FY '13 net other expense will be in the range of $180 million to $210 million. This includes the expected impact from the U.S. med-tech tax that will begin in January and higher royalty expense due to increased sales of Resolute Integrity. For Q2 FY '13, we expect net other expense to be in the range of $35 million to $45 million. Net interest expense for the quarter was $33 million. Excluding the $23 million noncash charge for convertible debt interest expense, non-GAAP net interest expense was $10 million. At the end of Q1, we had approximately $10.8 billion in cash and cash investments and $10.8 billion of debt. For FY '13, we expect non-GAAP net interest expense in the range of $70 million to $80 million, which excludes the noncash charge for convertible debt interest expense. Let's now turn to our tax rate. Our effective tax rate in the first quarter was 20.6%. Excluding the impact of onetime items, our adjusted non-GAAP nominal tax rate in Q1 was 20.9%. This quarter's tax rate was higher than expected and negatively affected by a finalization of certain tax returns and changes to uncertain tax position reserves, as well as the lack of the U.S. R&D tax credit extension. Together, these items totaled $13 million, which had a 120-basis point impact on our tax rate and over $0.01 impact on our earnings per share. For FY '13, we expect an adjusted non-GAAP nominal tax rate in the range of 19.5% to 20.5%. This does not include any benefit for the U.S. R&D tax credit, which has not yet been extended by Congress. Historically, the R&D tax credit has had an annual benefit in the range of $30 million to $35 million or approximately $0.01 per quarter. In Q1, we generated $1.2 billion in free cash flow, defined as operating cash flow minus capital expenditures. We remain committed to returning 50% of our free cash flow to shareholders, and during Q1, we repurchased $470 million of our common stock or approximately 1% of our outstanding shares. As of the end of Q1, we had remaining authorization to repurchase approximately 46 million shares. First quarter average shares outstanding on a diluted basis were 1,037,000,000 shares. Let me conclude by commenting on our fiscal year 2013 revenue outlook and earnings per share guidance. While we are encouraged with our top line performance in the past couple of quarters, we continue to be focused on delivering consistent results. At this point, we want to remain conservative, so we are not changing our FY '13 constant currency growth outlook of 2% to 4% from continuing operations. Although we cannot predict the impact of foreign currency movements, to give you a sense of the FX impact, if exchange rates were to remain similar to yesterday for the remainder of the fiscal year, then our FY '13 revenue would be negatively affected by approximately $400 million to $430 million, including a negative $140 million to $160 million impact in Q2. Turning to guidance on the bottom line. We continue to expect FY '13 non-GAAP diluted earnings per share in the range of $3.62 to $3.70, which implies annual earnings per share growth of 5% to 7%. It is -- it's also worth noting that while we do not provide quarterly guidance, when looking at the quarterly gaining of EPS consensus, we would not be surprised to see some models shift a couple of pennies from Q2 to Q4. As in the past, my comments on guidance do not include any unusual charges or gains that might occur during the fiscal year nor do they include the impact of the noncash charge for convertible debt interest expense. I will now turn the call back over to Omar who will conclude our prepared remarks. Omar?

Thanks, Gary. And before opening the lines for Q&A, let me just conclude by reiterating that although we were encouraged by our Q1 results, we recognize that we need to deliver this kind of performance consistently over the long term. While we're keeping a close eye on certain markets, on an overall basis, our end markets continue to stabilize. That trend, along with the breadth and scale of our business, our leading product portfolio, our recently launched products and our economic, value-oriented, go-to-market strategies, are beginning to make a difference. We're also preparing ourselves for changes in the global healthcare environment by implementing our strategies of economic value and globalization. We believe that all of this, combined with our strong capital allocation policies, positions us to create long-term value in healthcare. With that, we would now like to open the phone lines for Q&A. In addition to Gary, I've asked Mike Coyle, President of our Cardiac and Vascular Group, and Chris O'Connell, President of our Restorative Therapies Group, to join us for the Q&A session. [Operator Instructions] If you have additional questions, please contact our Investor Relations team after the call. Operator, first question, please.

[Operator Instructions] Your first question comes from the line of Matthew Dodds with Citigroup.

Omar, for you. The U.S. definitely has turned around for you the last couple of quarters, but if you look at emerging markets, 2 of the last 3 quarters now you've been below 20%. I think your goal is actually to be above 20%. So what are you seeing -- my sense is this has got to be China, Latin America, just looking at some of the growth rates. Is this execution, or is it more market?

I would actually say that it's more execution rather than anything else. As we've put our growth strategy in place, it's going to take a while, and there's going to be some level of variability quarter-over-quarter this period as we put our long-term strategies in place. I don't think it's the market itself because the healthcare demand is actually strong. Countries -- China is still investing heavily in healthcare. They're not -- despite the overall economy, there is some pressure where the government is very insistent on investing in healthcare. In places like Latin America and in India, there's demand from the population. So we don't see that as the market itself. We just need to make sure that our strategies all get into place. And over time, we will try to drive a little more consistency here, but that's what we're facing right now.

I mean, do you think 20% range for this fiscal year is still the goal?

That's certainly our goal, absolutely.

Your next question comes from the line of Mike Weinstein with JPMorgan.

So, Omar, you've gotten, with this quarter, your organic growth back up to what looks like about a 3.5% range, so a nice quarter. A couple of businesses that appear to hold you back a little bit this quarter is, one, the pacemaker business and, two, Diabetes was a little bit light in the U.S. So I was hoping you could talk about, and maybe Mike can jump in, on the pacemaker market, because it's not a Medtronic issue. Why are -- not only has pricing gotten a little bit worse in pacemakers but volumes appear to be contracting. I would love your opinion on that. And then two, maybe for Chris, maybe you can just comment on why the U.S. Diabetes business was flat this quarter.

Sure. Let me make a few comments upfront, and then I'll ask both Mike and Chris to make some comments as well. First, the Pacing market, we see about 3 or 4 reasons here in general. The -- and our results were a bit weaker than expected. It was mostly price. And remember, we anniversaried our Revo MRI launch, so that's had some impact. But also, the destocking and the reduction in bulk purchases in Pacing was a factor. But in the end -- also, the procedure volume was lower. And we don't -- haven't quite gotten to the bottom of exactly why. And I'm sure Mike will have some thoughts on that, so I'll let him comment on that in a minute. In terms of Diabetes, the results were primarily related to a replacement cycle issue. And we were building excitement for the new products and it might remain a challenge until we get our FDA approval in FY '13. But it's primarily a replacement cycle issue in the U.S. That's what we're seeing. So, Mike, you want to go first, if you would, about the pacing market question.

As Omar mentioned, it is the 3 items that he outlined. And on the procedure volume side, I would say that, really, we saw the procedure volumes starting to drop in the first half of FY '12 and they actually began to stabilize on sort of market implant rates here in the U.S. in Q3 of last year. So we're now heading into the third quarter where they've been relatively stable, in fact, up slightly. So we think the prior-year comparisons are showing significant declines. But as we get later into the year, we think that those will normalize. As for what's behind it, we've been trying to dig into that and really have not come up with good answers. So it looks like the general economy may have something to do with that. But generally speaking, we don't have a good answer for it other than to say it appears to now have stabilized, and we should start to see that by our Q3.

And, Chris, can you say a few words about the Diabetes?

Yes. Mike, certainly, the growth in the U.S. was a little more modest than we expect. And the market, as we've been commenting in recent quarters, has been a little bit softer in the recent year or so with the consumer economy. As Omar said, our replacement cycle is currently negative in the U.S. However, I will say that our new pump starts, what we call new pumps, our new patients, was positive in the quarter, which makes us feel good. In addition to that, the international business was very strong. The big event in the U.S. is obviously going to be the launch of the 530G at the end of the fiscal year. So we're all looking forward to that.

Your next question comes from the line of David Lewis with Morgan Stanley.

Gary, just a quick modeling question here. Just the second quarter commentary you made versus consensus numbers of the $0.02 potentially moving from the second to the fourth. I'm just sort of thinking about the first quarter. SG&A actually would have been stronger if you would make the -- take out the Greek adjustment. And thinking about R&D being heavier in the first quarter, could you just kind of provide us a little commentary on why the second quarter numbers would be a little lower than consensus, or why that? Do you see those $0.02 moving from the second to the fourth?

Yes. Well, all we're trying to get that -- and we're not trying -- I mean, all of you have to adjust your models based on what you think is appropriate. All we know -- we're highlighting is the fact that for the full year, and what you saw here in the first quarter, we've given guidance of earnings per share growth of 5% to 7%. It was 8% in Q1. And as you said, it could have been a little better without the SG&A bad debt expense we had. But the issue you have in Q2 last year, the comparison, there was a couple of cents in there related to a gain on our investment in PEAK and Salient. And so if you just look at the consensus currently, it would indicate earnings per share growth of 10% after adjusting for that in Q2, which is obviously significantly above where we were here and where our guidance is at, and that's with assuming the R&D tax credit is not extended yet. So the idea that Q2 would have the higher earnings per share growth versus what I think right now the consensus is showing is a very low earnings per share growth in Q4, we're just saying is the models look like they could probably be shifting a little bit more from Q2 to Q4.

Okay. Maybe just a quick follow-up here for maybe others in the group. On the Cardiovascular, specifically Coronary side, obviously, you saw another very strong quarter, second sequential quarter. Can you just give us a sense of where you think you are? You talked about some of this at the Analyst Day in terms of account penetration with RESOLUTE. I think you mentioned at the Analyst Day that you were maybe 25% to 30% of accounts still had not been penetrated. Maybe just give us an update on where that penetration stands, and can we see another very strong performance or an accelerated performance in the next quarter?

Sure, yes. I mean, first, let me make a comment and say that we continue to be pleased by the results. And every time I go out in the field and talk to customers, there is strong acceptance of this product. And I can see personally, when I go to the field with our own CRDM reps, that -- how engaged they are in using their relationship to open the doors for overall CVG strategy to work. But let me ask Mike to give some more specifics.

Sure. I think at the analyst meeting, we talked about targeting a 25-plus percent market share. We would estimate out of the data that we saw here for Q1, we're probably sitting around a 27% market share. I think we've gotten through the primary accounts that -- where we had strong positions with the Integrity bare-metal stent prior to the release of the Resolute Integrity. And now we're really going to be relying on the broader CVG strategy, the leverage that we have with our commitment to next-generation technologies in interventional cardiology like renal denervation, like transcatheter valves, as well as the broad strategic account management programs that I outlined at the analyst meeting that are really -- help you drive economic value in these accounts. So we think there is still upside to share available to us, although it certainly won't come in the chunks that we saw the last 2 quarters. But we do believe that there is still meaningful share upside for us on the Coronary side.

Your next question comes from the line of Kristen Stewart with Deutsche Bank.

I was wondering if you could maybe quantify or give some color just around renal denervation sales, as well as TAVI this color -- this quarter, just around whether or not you're still seeing renal denervation grow. Some of your comments suggested that it was -- seems to be getting a little bit tougher in the pre-reimbursement environment, and I think you had mentioned TAVI was up double digits. But any commentary on what you're seeing just kind of in the overall market?

Yes. Kristen, I'm going to ask Mike to take this one.

So on the renal denervation side, renal denervation continues to be the fastest-growing product line that we have within CVG. So it is a very nice growth driver for us. But this is very much a market development exercise. There are significant issues for us to focus on in terms of market development, including working in referral base, these are physicians who basically have patients who have not been generally referred for device interventions so we have to very much focus on developing those referral channels, and also reimbursement. As you know, in Europe, they're not looking for new things to pay for in healthcare budgets, so we have to use the very compelling data that we're generating to get reimbursement. We continue to see progress on both of those fronts. In fact, in Europe, this past quarter, we have really begun to focus our focus on renal denervation reps on market development and are starting to use our Coronary reps to help with the actual procedure support, which I think is going to really help us continue to develop those referral chains. And then on the reimbursement side, the data continues to be extremely strong on the sustainability of the benefit for hypertension reduction renal denervation, and we continue to work to expand the reimbursement levels throughout Europe. On the transcatheter valve side, the market growth rates that we talked about for Europe on the TAVI side were in that 15% to 18% kind of range, and we continue to expect that as the growth rates that we will see in that area. We continue to split the market with our primary competitor in that space, and we continue to have very robust new product flow with the Evolut product introduction here just in the past quarter. So we expect to continue to see strong growth in that segment of our business.

And would you be willing to just kind of give out a renal denervation number or comment if it was higher sequentially?

No. I think at this stage, I think we've said we have to...

It's slightly higher sequentially, but we don't have the number to give out at this point.

Your next question comes from the line of Rajeev Jashnani with UBS.

My question was on the ICD market in the U.S. I think you talked about implants being up 4% year-over-year. And I was wondering if you could just give a little bit more in terms of your expectations for volume and pricing, not just for Medtronic but really what you're thinking the market is at right now.

The overall market is down in the U.S., and -- but we do see the implant volumes growing. But at the same time, as I pointed out earlier, the hospital destocking is a real factor. I think hospitals are working to reduce their inventories and reduce their level of bulk purchases, like we said. And for us, actually, in many ways, we can use that to our advantage, in the sense that the level of discount that we have to give out for that instead we can transfer that to multiline deals, which are probably better for us. But we do see an overall reduction in the market by both of those drivers, although implant volumes appear to be relatively stable. But I'm sure Mike can add a lot more color to this. Go ahead.

So for the U.S. market, we are seeing modest low-single digit improvement in the implant growth rates for the market, as obviously, we've now anniversaried the issues with the original DoJ investigation, and now we're starting to see a return to growth. Pricing continues to be obviously a drag on the market but still low-single digit sort of pricing pressure. So as you can see, we're encouraged, going forward, that we're going to continue to see implant growth rates. And obviously, we think we have upside not only from that perspective but also in overall market share, as we are now going to be heading into a new product release cycle with the Viva/Brava products we just announced, the CE Mark in Europe for those 2 products. We will have the EVERA product line coming in, in the fourth quarter, and then those product lines will come to the U.S. next year, including the Advisa MRI pacemaker next year. So we see some nice catalysts for continued market share capture with that product flow coming.

And would it be fair to characterize your expectations for both the U.S. and x U.S. markets as roughly flat on a revenue basis?

That would be a reasonable assumption, flat to slightly down.

Your next question comes from the line of Bob Hopkins with Bank of America.

So I wanted to ask a few questions on Spine. You had the best Core Spine x Kyphon growth that I think you've seen in quite some time, and so I was wondering if you could just flesh that out a little bit. Do you really think that the market is improving, or is it that you feel like you've -- that you're gaining share? Is it mix? Just a little more color on what's driven the improvement in the Core Spine x Kyphon growth rates that you highlighted today.

I think it's both. The market is stabilizing to some degree. But I do think that -- we've been working and getting our new product launches tighter. And the procedures we're creating, surgeons -- there's a lot of acceptance on our new procedures. And I don't want to minimize our synergy with capital equipment purchases. When you put all that together, I think we are -- our performance is definitely improving, and it's not unreasonable to expect us to gain a little bit of share in Core Spine as we go ahead. I think that's something that's in our expectation, and we can prove that. It's very early. It's only one quarter that we've had this kind of performance. But we're encouraged to see the thing turn around. I think -- Chris, I'm sure you have some comments on this, so go ahead.

Sure, yes. Bob, that's exactly right. The market is stable, and I think what's going on is our relative performance is definitely improving. And a lot of that is just the story we've been continuing to tell about the new products. So you take the Solera, for example, we're out in force this summer with the 5.5/6.0, which is the larger rod diameters, and we've seen that business really double sequentially as we've got more sets out into the field. Lot more navigated spine surgery going on. Keep in mind, we have an installed base now of O-Arms in the U.S. of 250 and over 1,000 StealthStations, with those numbers even bigger when you look at the global picture. So clearly, some of the strategies we've been developing, both on the individual product line segments, as well as with the procedural innovation, are really moving the needle. Another example is the MAST MIDLF procedure we talked about at the analyst meeting. We now have over 300 surgeons utilizing that procedure. We've done over 1,000 procedures. So we're -- we are pleased with our trajectory at this point and obviously see that to be a continuing story.

And then just as a follow-up on Spine. In the Yale study, you mentioned it'll read out in the next couple of months. I'm just curious, do you know the conclusions of the Yale study at this point, and are you optimistic relative to the outcome or are you blinded to that?

No. We're really blinded to that. That's completely outside. It's a third-party thing, and Yale is managing that. And we're waiting for the results, just like everybody else.

Do you know specifically when we will see that?

I think within the next few months. Certainly before the end of the year, we are expecting to see that.

We're expecting sometime here in the coming months, but we think again -- the timing is still all tied to Yale. But we are expecting in the next couple of months. That's the expectation from them.

Your next question comes from the line of David Roman with Goldman Sachs.

It's actually Topher Orr in for David. I just had a quick question as it relates to earnings leverage. This quarter, obviously, you posted about 5% constant currency top line growth with 8% EPS. Given that you guys maintain guidance in the 2% to 4% range, if we were to move lower, say, just arguments sake, in -- more in the 3% range for constant currency growth, how should we think about EPS leverage?

I think our range of 5% to 7% still holds, and we are confident that we can deliver on that just -- and sort of take into any variables that come our way. I think beyond that, Gary, maybe you have some thoughts.

Yes. I mean, as we indicated, we -- obviously, on a constant currency basis, as we indicated, we did 5% this quarter. Now as reported, obviously, it's 2%, and so the earnings per share is as-reported number. So we've got to cover all the foreign currency negativity to get to the bottom line. So we did that and made the investments we needed here in the first quarter. But as we indicated in my comments, the reality is we are expecting leverage for the full year. And the 2% to 4% guidance, if you pick 3%, that's where -- for the year what you pick for our growth rate, we are still -- our earnings per share guidance is still in that 5% to 7% range. So there is still leverage. We're expecting 30 to 50 basis points of leverage in SG&A. We're expecting the R&D expense for the year will not be quite as high as we saw here in Q1 as we kind of go forward through the rest of the year. And as we highlighted, depending on what you assume in the tax rate, there's obviously should be -- assuming the R&D tax credit gets renewed, there's even more additional leverage there. So there's a lot of different factors that we think will continue to provide additional leverage as we go through the year, even in light of some of the headwinds we're going to have to face with the medical device tax, et cetera. So our guidance assumes that we do achieve continued operating leverage in the current year, and we have every expectation to deliver on there.

Then just one quick follow-up if I could. Omar, I know in the past you have -- you've talked about kind of May, June of 2013 time frame for completion of your overall in-depth business analysis. I was wondering, do you have any update on timing. Are you guys ahead or behind on that schedule? Or do you still anticipate sort of the same timing in terms of completing it?

No. We're well in the process of doing that. I mean, this is like a continuous effort and we've been through a few rounds of that, and we've analyzed our businesses. At this stage, we're okay with the portfolio. I think there are some sub-segments which we're looking at, some smaller businesses, and we will optimize our portfolio accordingly. But we've been through one round of analyzing our businesses, and these things aren't that black and white. There are some areas that we are looking at, and in some areas we have to shore up with, perhaps, acquisitions all around the guidelines that I've said before. And in some areas, we don't have enough critical mass, and we're seeing what the best way there is to achieve that. So we will look at this thing on an ongoing basis, and the actions are also dependent on exactly what we find and then the actions result in other actions. So it really isn't black and white, so I wouldn't wait for some kind of milestone event, where suddenly we decide that we've got a dramatically different portfolio. We'll adjust this as we go along.

Your next question comes from the line of Bruce Nudell of Crédit Suisse.

One question for Mike and one question for Gary. Mike, it seems like the TAVI program will hit the U.S. endpoints is my guess anyway. Do you feel that the kind of blemishes ascribed to the device, paravalve leak, pacemaking, maybe left bundle branch block, if you do hit the endpoints, would be a sufficient stumbling block to create a high risk for approval or delay?

Go ahead, Mike. I think Mike should take this one.

So, Bruce, I think I'd take issue with your underlying assumptions there. I think as we look at the high-quality clinical evidence that's being generated here, especially, obviously, our U.S. clinical study and then the advanced registry, which really is extremely well controlled and supervised registry study, I mean, we're seeing just excellent performance from the overall product. And I think it's dangerous to look at data that may be several years old when the device was used in different ways before the ACCU TRACK technology was available, when there were different implant techniques in terms of depth of placement of the valve. The current data, and I think especially the current reports that you're seeing, show really excellent performance on overall perivalvular leak, as well as pacemaker implants now in sustained use down in the low teens with -- even reports down around 10%, 11%. So we feel very good about the trajectory of the program, and we think that the clinical evidence that's being generated, it is very high quality and very much supported that this is a technology that really is a very strong performer. And if you look at overall market share positions in Europe where this is released, I mean, we are essentially neck and neck with our primary competitor in those areas, which I think is a testament to the performance of the technology. So we feel very good about it.

And, Gary, just -- is there -- is it draconian kind of outcome for BMP figuring in into the guidance range for revenue this year, or is that really just a very remote kind of possibility that's not seriously impacting your guidance range?

Yes. I mean, obviously, Bruce, what our guidance is assuming right now is that the INFUSE product line continues kind of at the levels that it's been in the last several quarters. We'll all have to wait and see what happens with the Yale results. And how that would potentially impact the guidance, we don't know at this point in time and then it could have been -- if it's positive, we see that could be a potential upside. If it's continued concerns, obviously, that could be potential negativity. So we've tried to bring some of that in there. But the reality is it's kind of assuming that we kind of continue along with the same kind of levels with INFUSE as what our guidance is based on right now, and we'll have to see what the results of the Yale studies indicate.

I think that's probably the best way to put it, Bruce. It's -- we're assuming kind of where it is right now. And there is some range in our guidance, so it could -- and then also depends on other things that happen. That's not the only factor. But it does probably -- we can absorb a little bit of negativity, but also there may be positive results as well. So we really don't know, and so we left it the way -- the way it's stabilized as of today.

Your next question comes from the line of Josh Jennings with Cowen and Company.

I guess first, I just wanted to hone in on the ICD business. This business stabilized quicker than we anticipated, and you guys outperformed the market. Can you just talk about the inter-quarter cadence of the performance of that business unit? Would -- did you see any improvement in the back half of the quarter, in June and July?

I -- Mike, probably. I don't know anything of note, but, Mike, you're closer to it.

I wouldn't comment on this quarter trends. I think generally speaking, we feel like we're seeing a nice return in terms of stabilization of the market implant rates for ICDs, and we're also obviously seeing, I think, some very nice share trends for us. I think we referenced in our introductory remarks here, we're seeing a nice improvement in lead-to-can ratios in the ICD side. They are now back to pre-Fidelis levels, actually above pre-Fidelis levels in terms of those ratios. And we're seeing a nice improvement in terms of overall market share on the replacement side, which actually even highlights the lead-to-can ratio improvement, because obviously, on those implants, we're not getting the lead. So we really do feel as though the trends are really being driven by market share capture for us and stabilization of implant growth rates, and obviously, we have the headwind of the pricing pressure, which, as I mentioned, is kind of a low-single digit drag on the overall market. So generally speaking, we're going to -- we feel like those trends are likely to continue.

This is Gary. Just to add one comment to what Omar and Mike said is that we do -- we have indicated that what we did see in the historical data was that June and July of last year was kind of -- seem to be the kind of the valley as far as how -- of where the market went. And that's where we started to saw it starting to stabilize was after that period of time. So the comparisons, clearly, have gotten better as we've gotten to this point, and now we're comparing to the low point of where we were at previously.

And the other thing that I would just mention is that Omar referenced the reductions in hospital inventories. I mean, those were meaningful in the quarter. We expect that our overall inventory shares of our products would probably be down over 15% in the U.S. hospitals. So to be showing absolute revenue share capture against that headwind, we think, is a significant testament to the fact that we are getting nice share capture trends. But again, we expect those trends to continue as well, the hospital inventory compression.

And can you just follow that up with your outlook on the o U.S. ICD marketplace from a pricing and volume standpoint? And lastly for Mike, you talked about some of the -- those metrics on the CoreValve and some of the data that's being generated on the newer technology with the ACCU TRACK. Any time lines in terms of when we can see some of that in print and -- just so people can get more conviction around that improvement?

Go ahead, Mike.

So on international ICD trends, I think the -- in Europe, we actually are seeing very similar trends in terms of procedure growth and pricing pressure. They're both very similar to what we saw in the U.S., and so I wouldn't highlight those as being meaningfully different. I would point out that our ICD shares in Europe are at the highest level in probably 3 years. And then we will continue to release data on the advance registry outcomes as that data becomes available, so you'll continue to see that come out at the major meetings over time. And then of course, the U.S. submissions are right on track with what we had discussed at the analyst meeting 3 months ago. So there's no changes to timing expectations there.

Your next question comes from the line of Derrick Sung with Sanford Bernstein.

Gary, I just wanted to start by following up on your revenue guidance. I appreciate the conservatism that you've mentioned. But where do you think -- where do you see potential risk for a deceleration in sales growth versus what you're seeing this quarter? You've already mentioned that INFUSE is probably not one of the areas that you could see a -- you're anticipating further deceleration. So where are the potential areas of risk here that might get us back to kind of more the midpoint of your revenue guidance?

Let me just -- first of all, the INFUSE, there may well be risk. We just said that we modeled it flat. But in that sense, we model a lot of things a certain way. And there's definitely risk -- potential risk in INFUSE, and that's one of the factors in our range. Other areas like Europe, I mean, you just -- you can pick up the newspaper and look at what's going on in Europe. And again, our view has been and it's been confirmed that the healthcare budgets are being protected, and our teams are saying that. And they're executing and we're seeing the numbers. But you've got to be a little cautious about what's happening there, and we will watch them very carefully. I think outside of that, I am a little concerned about emerging markets as well, like I mentioned earlier. I think it will get there to 20%. I think our modeling -- actually, the financial modeling doesn't quite have it at 20%, so I'm not sure there'll be downside there. I think, Gary, you can add a little bit more color.

Yes. I mean, I think Omar has indicated some of the -- clearly, some of the risks that we still see in the quarter and are assuming in the year. And that the reality is, Derrick, I mean, obviously, we're encouraged over the last couple of quarters. We've seen some -- a return to growth, and obviously, we've seen some real positive results coming from Resolute Integrity. And we will be anniversary-ing the PEAK and Salient acquisition here in this quarter, so that's been a little bit of an upside that we won't have as we go forward. That being said, I mean, we're giving guidance of 2% to 4%, and we're just -- our markets have been volatile over the last couple of years, and we are seeing stabilization, which is good. But we're going to be cautious until we see that those continue to be stable and continue to grow. And so as Omar indicated, let's see a few more quarters of that happening before we get too far ahead of ourselves and report our guidances. And there are still risks out there in some of these markets. We -- our teams are managing relatively well at this point through them. But at some point in time, does that have an impact on us also, whether it's Europe or some of these other areas. So that's why we kept the guidance where we're at, at this point. And we're hopeful that we're being conservative. But right now, let's not get ahead of ourselves.

And I'd like to also repeat the fact that consistency in delivery is very important for us. And as I said before, the guidance is irrespective of market conditions. I can't be absolutely 100% on that, but we will do our very best to absorb hits to the market or any uncertainties that are outside of our control. That's why the guidance is where it is. And as we see the our overall growth rate from our businesses grow, we'll be more comfortable. But one quarter is not enough, not even close for us to draw a conclusion like that, and we need several more quarters of dependable, consistent performance before we can claim any sort of success.

And if I could just sneak in a quick follow-up on your DES business. You're showing clearly some very impressive share gains off of Resolute Integrity, but the overall global DES market continues to decline. Now I just wanted to get your thoughts on how you think about that DES market beyond your share gains. And once you anniversary those share gains, how do you kind of think about your business moving forward?

I think we've got our pipeline growing. But again, Mike, you're best to comment on it.

I would point out that we've not even entered the Japanese market yet with that product, which, as we bring that out in the second largest DES market in the world, we're going to see a year-plus worth of continued growth driven from that. And then obviously, as we continue to work that pipeline but then begin to expand our new product entries in the international cardiology space to include renal denervation, to include transcatheter valve technologies, we think we have a sustainable interventional cardiology growth profile here for years to come. So to us, it's all about a portfolio of products, some at various stages of their product life cycles, and we continue to see that. And not only have those as growth drivers but have that as a part of our overall program to have international cardiologists look to Medtronic as the partner that they want to have long term, which we think is going to help us move up from where our share positions are on DES, even from where we are.

Your final question comes from the line of Joanne Wuensch with BMO Capital Markets.

It's really 2 parts. The first one is, as we've been hearing about inventory management of the ICDs and pacemakers now for several quarters, at what stage is an inventory management done? I mean, for you to be able to drop 15% this quarter in one of those segments, that's a lot. And then the second thing is, as I was listening to your verbiage on M&A and a more ROIC-focused management team, are you trying to tell us something?

I mean, the second one, first, I'm trying to tell you that ROIC is a big focus for us. And I just want to emphasize that, and that we'll be very disciplined with our acquisitions. And the criteria that we've made out is very clear. We want to cover dilution. I mean, there are always exceptions, but the hurdle will be very high. And we want to cover first within the business, the business here at making acquisition, and the EPS -- potential EPS dilution, then within the corporation. And as a last resort, we may decide to pass it on to the shareholders. We'll have to justify, and that hurdle is very, very high. And if you do that, then that drives better ROICs, and we're looking at ROIC as a very active measure. And to make it even stronger, we're making sure that our management team and beyond are being compensated as a result of that. So that's what I'm trying to say, that ROIC is extremely important.

As for the inventory management questions around the pacemaker and ICD market, we're very much managing that from the standpoint that we're -- as Omar mentioned, cutting back on the extent of discounting that we'll provide for bulk purchases in that area, because frankly, we find that very matchable by competitors. Whereas if we use that same level of discounting in broader multiline product deals, especially now that we have Resolute Integrity in our bag and then, obviously, leadership positions in multiple cardiology areas, we think those are much more difficult for competitors to match up to. So we are very much in the process of managing those inventory reductions. And as you can see, we're able to do that in the context of the guidance that we've provided.

Yes. And then the hospitals actually -- as I visit hospitals, look, the cost sensitivity in hospitals is very, very high, and they're looking over their books with a great deal of detail. And I find some hospitals and hospitals systems are finding this to be an area where they're optimizing their inventory balance, which any good business ought to do. And I've got no idea how much more optimization there is to go, but like Mike mentioned, we've got pretty good strategy that deals with it. So I think that's where we stand on that one.

That does conclude our question-and-answer session for today. I hand the program back over to management for closing remarks.

Okay. Well, thank you very much for all your questions. And on behalf of our entire management team, I'd like to thank you all again for your continued support and interest in Medtronic. We look forward to updating you on our progress on our Q2 call in November. So thanks again.

That does conclude today's conference call. You may now disconnect.